MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD® 100NX CASSETTE; STERRAD® 100NX STERILIZER

Catalog Number	10144
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Skin Discoloration (2074); Skin Burning Sensation (4540)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hcw was re-trained to always wear appropriate personal protective equipment (ppe) when working with sterrad systems.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by advanced sterilization products, or its employees that the report constitutes an admission that the product, advanced sterilization products, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Asp complaint ref #: (b)(4).
Event or Problem Description
A customer reported a female health care worker (hcw) experienced a skin reaction of burning/tingling sensation and discoloration on the hands when replacing an ejected sterrad® 100nx cassette from the unit.It was reported no damage or leak was observed for the new cassette, and the hcw handled the cassettes without wearing gloves.The affected areas were immediately washed with water, and the symptoms resolved within two hours without requiring medical treatment.The h2o2 skin reaction was assessed to be a minor injury since it resolved without medical intervention; however, this event is being reported as a malfunction report subsequent to a previous serious injury.
Additional Manufacturer Narrative
Asp investigation summary: batch record could not be reviewed since the suspect sterrad® 100nx cassette lot number was not provided.Trending analysis could not be conducted since the suspect sterrad® 100nx cassette lot number was not provided.Review of risk documentation shows the risk for exposure to toxic or corrosive material to be "low." the suspect sterrad® 100nx cassette was discarded and not available for evaluation.Additionally, the lot number was not available and user error associated with the event was identified; therefore, no supplier investigation was performed.The most likely assignable cause for the skin reaction can be attributed to user not following the sterrad® 100nx user guide for proper handling of cassettes.The hcw was retrained to always wear appropriate personal protective equipment (ppe) when working with sterrad systems.Asp will continue to track and trend this issue.Asp complaint ref#: (b)(4).

• Brand Name: STERRAD® 100NX CASSETTE
• Common Device Name: STERRAD® 100NX STERILIZER
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer Contact: mark ongkeko ; 33 technology drive; irvine, CA 92618 ; 9495619452
• MDR Report Key: 16556965
• Report Number: 2084725-2023-00059
• Device Sequence Number: 2970177
• Product Code: MLR
• UDI-Device Identifier: 20705037014900
• UDI-Public: 20705037014900
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K071345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 10144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown